Catalog Number

SN3185A4

Brand Name

Endure

Version/Model Number

SN3185A4-0520

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

1e78c231-080b-4bbb-93a4-9af9966baf6c

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

00840118604581

Quantity per Package

100

Contains DI Package

00840118604574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box